Clinical trial · Interventional
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
PREDIX HER2 - Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
NCT02568839CI-TRIAL-00046608PREDIX HER2active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HER-2 Positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel + trastuzumab sc + pertuzumab | Drug | — | UNRESOLVED |
| trastuzumab emtansin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A standard treatment
- description
- docetaxel + trastuzumab sc + pertuzumab. Treatment with all three drugs is given on day 1, repeated every three weeks. Six courses of preoperative treatment. Response evaluations after every 2nd course. In case of no change (NC), treatment is switched to arm B. Postoperatively, patients receive 2 courses of treatment with the combination epirubicin + cyclophosphamide (EC), followed by adjuvant trastuzumab, radiotherapy, eventually endocrine treatment.
- interventionNames
- Drug: docetaxel + trastuzumab sc + pertuzumab
- type
- EXPERIMENTAL
- label
- B experimental treatment
- description
- trastuzumab emtansine. Treatment is given on day 1, repeated every three weeks. Six courses of preoperative treatment. Response evaluations after every 2nd course. In case of no change (NC), treatment is switched to arm A. Postoperatively, patients receive 4 courses of treatment with the combination epirubicin + cyclophosphamide (EC), followed by adjuvant trastuzumab, radiotherapy, eventually endocrine treatment.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker 3. Tumor and blood samples available. HER2 type confirmed by ISH 4. Age 18 years or older. Elderly patients in condition adequate for planned therapy 5. Primary breast cancer \>20mm in diameter and/or verified lymph node metastases 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF ≥55% 8. ECOG performance status 0-1 9. Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available Exclusion Criteria: 1. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum 2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix 3. Patients in child-bearing age without adequate contraception 4. Pregnancy or lactation 5. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders
References
Publications (3)
- DERIVEDZhu Y, Zerdes I, Matikas A, Cruz IR, Bergqvist M, Elinder E, Bosch A, Lindman H, Einbeigi Z, Andersson A, Carlsson L, Dreifaldt AC, Isaksson-Friman E, Hellstrom M, Johansson H, Wang K, Bergh JCS, Hatschek T, Foukakis T. The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the Swedish phase II randomized PREDIX HER2 trial. Breast Cancer Res Treat. 2024 Apr;204(2):299-308. doi: 10.1007/s10549-023-07200-x. Epub 2024 Jan 4. PMID 38175448
- DERIVEDMatikas A, Johansson H, Gryback P, Bjohle J, Acs B, Boyaci C, Lekberg T, Fredholm H, Elinder E, Margolin S, Isaksson-Friman E, Bosch A, Lindman H, Adra J, Andersson A, Agartz S, Hellstrom M, Zerdes I, Hartman J, Bergh J, Hatschek T, Foukakis T. Survival Outcomes, Digital TILs, and On-treatment PET/CT During Neoadjuvant Therapy for HER2-positive Breast Cancer: Results from the Randomized PREDIX HER2 Trial. Clin Cancer Res. 2023 Feb 1;29(3):532-540. doi: 10.1158/1078-0432.CCR-22-2829. PMID 36449695
- DERIVEDHatschek T, Foukakis T, Bjohle J, Lekberg T, Fredholm H, Elinder E, Bosch A, Pekar G, Lindman H, Schiza A, Einbeigi Z, Adra J, Andersson A, Carlsson L, Dreifaldt AC, Isaksson-Friman E, Agartz S, Azavedo E, Gryback P, Hellstrom M, Johansson H, Maes C, Zerdes I, Hartman J, Brandberg Y, Bergh J. Neoadjuvant Trastuzumab, Pertuzumab, and Docetaxel vs Trastuzumab Emtansine in Patients With ERBB2-Positive Breast Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1360-1367. doi: 10.1001/jamaoncol.2021.1932. PMID 34165503